Systems of organ procurement

 

If a person is deemed to be a suitable potential donor, an attempt must be made to obtain his or her organs for transplant purposes. For this to be possible, consent to removal will need to be obtained, with various procurement systems being in use that enable the wishes of people concerning donation to be determined, both while alive and once dead. Here, the legal system plays an important role in affecting the manner in which organs can be acquired, as procurement systems that may be legal and successful in one state may be deemed undesirable or useless in another country. This is since people in different states may have different social value systems that can greatly influence their acceptance of the conditions and operating procedures of a particular system, although in all cases, altruism on the part of the person whose consent is desired is held to be a legal and moral prerequisite to organ removal. However, each new discovery and improvement in transplantation means that the ethical, legal and social debates that currently taking place on this topic are only likely to be exacerbated further, with questions relating to the relevance of subjective value judgements, such as the morality of payments, being likely to come under increasing public scrutiny due to the fact that human lives are at risk and intimately affected by what procurement policies are used in a country. In this section, we review the attributes of the main systems currently used to obtain organs for transplantation from both living and dead donors. 

 

i) Informed consent

Traditionally, organs and tissues have been acquired through the system of informed consent, where a patient who decides to “opt-in” to the donation system must explicitly provide consent before any organ removal can take place. With living donation, consent can be obtained by having a living donor sign an affidavit confirming his wish to donate and acknowledging the risks incurred, while with cadaveric donation, organ donor cards, which are legally valid documents signed by a person while alive indicating a wish to give organs upon death, can be utilised. However, with cadaver organs, reliance on donor cards is often negligible, for in most cases, regardless of whether or not one of these completed cards is available, the family, who are usually the next of kin, will be approached in order to approve of a donation. This emphasis on familial consent is primarily due to their proximity to the patient, as it is felt that the family may have a greater knowledge of a person’s personal opinion on the issue of organ donation than anyone else, and may therefore be able to confirm whether a person was truly in favour of having organs removed from his or her body. 

The origins of this system date back to the 1960s, when there were only a few candidates awaiting transplantation and when the majority of potential donors were living rather than dead. At this time, lawmakers were mainly interested in protecting people, especially those deemed unable to speak for themselves, such as children and the mentally handicapped, from engaging in what was perceived to be the risky act of removing organs[1]. In order to ensure that people were not coerced into agreeing to organ removal, strict regulations were introduced where the informed consent of potential living donors was required, where they needed to be fully informed of the risks they faced before they could agree to such an act. In the years that followed, as cadaver sourced transplantation became clinically viable, this form of consent was extended to cover the wishes of people who wanted to donate their organs for use in others after death. This was a drastic departure from the procedures that then existed, as consent to post death organ removal was generally restricted to donation involving approved scientific research, with most laws of the time prohibiting organ removal due to fears of a recurrence of Victorian era grave robberies[2].

The basic philosophical foundation behind this form of donation is the belief that each person has a property right over his body, and can, within bounds, do with it as he pleases, both while alive and when dead. A conservative interpretation of this view holds that after death, the family are the legal owners of the deceased’s body, and are thus solely entitled to decide on its fate, while a more liberal position is that the deceased alone has the right to decide on what happens to his body after death, with the next of kin merely being seen as representatives entrusted with conveying and enforcing his wishes. An underlying precept associated with this activity is that it is deemed to be a worthwhile way of expressing altruism, with much of the literature on this topic using “altruistic language to encourage people to consider organ and tissue donation as giving the gift of life”[3]. Here, people who donate organs are analogous to the altruistic blood donors whose motivations were examined elsewhere, since their sole apparent reason behind giving appears to be a desire to help other humans in need of medical assistance. As with their blood giving counterparts, the non-existence of payment means that the only reward available to these donors is the Kantian benefit of knowing that the loss of their own lives can help others gain a new lease of life, although the most obvious difference is that they can only make a single donation of organs in their entire existence.

While it may be lauded for its emphasis on individual autonomy, it is an “undeniable fact that the current system, despite 30 years of experience based on altruistic donation, has yet to meet this need”[4] of ensuring that the number of organs supplied matches the quantity demanded by those patients on transplantation waitlists. There are many reasons behind the failure of this system – while some are general factors that apply to all organ procurement systems and will thus be examined elsewhere, others are specific to the principle of encouraged voluntarism and are thus examined here. First, many people are loath to contemplate their own deaths, with there being little intrinsic interest but much fear surrounding the end of life[5]. Consequently, despite efforts to increase public awareness on this issue, people may not make plans as to how their bodies are to be disposed of nor will they discuss organ donation with their relatives, which creates substantial uncertainty should they die in conditions where their organs could be extracted for later use. Furthermore, despite assurances to the contrary, people may not carry donor cards if they distrust the intentions of others, with a popular fear existing that should a person have a donor card, he might not receive the same degree of aggressive medical attention as someone without a card. However, the most important flaw with this system that many of its supporters refuse to concede is that it probably overestimates the extent of generosity of most individuals[6]. While people may be willing to make bequests of money and other assets, they may, due to a number of reasons to be examined in greater detail later, simply feel that their bodies should be declared off limits to strangers after their death. As such, it is inaccurate to use other forms of altruistic activity as a benchmark to determine the extent to which the specific form of altruism that is organ donation is likely to be undertaken.

 

ii) Presumed consent

To avoid the problems associated with obtaining consent when dealing with potential cadaveric donors, an increasing number of countries have, since the 1980s, switched towards using organ procurement systems based on the principle of presumed consent. Here, “on determination of death, it is presumed that the deceased has consented to donation unless there is actual knowledge of an objection on the part of the deceased or their next of kin”[7]. While informed consent is an “opt-in” form of donation, as the donor must express a wish to donate, presumed consent is the exact opposite, in that it requires people to “opt-out” of the donation system[8]. Rather than have those people who support donation carry cards or other documents indicating their desire to donate, the burden of consent is now shifted to those who do not wish to become organ donors, who must themselves carry cards or issue some other directives stating that they do not want to have their organs removed after death[9]. An economic analogy would be to say that we have a form of negative response marketing, where failure to object is understood by the medical authorities to imply consent on behalf of the individual concerned[10].

The underlying rationale behind this system is the assumption that most people support organ donation and have no problem with having their organs removed. This view is based on the findings of various opinion polls and surveys, which find that while most people support the idea of organ transplantation, they might, for various reasons, never actually leave written or oral accounts of their wishes on this issue. Such a dichotomy is undesirable, for even though these respondents state that they approve of donation, organ removal will not be undertaken if there is a lack of knowledge on the side of the medical authorities concerning their wishes. Consequently, government will intervene to end what may be termed an information asymmetry problem by institutionalising the informally expressed altruistic desires of its citizens when it comes to organ removal.

Should citizens, for whatever reason, not wish to have their organs removed, they are entitled to publicly state this objection, in person, by post, or through some other signalling mechanism, with the objection being registered on a central database of objectors that can be accessed by medical institutions. When a potential donor enters an intensive care unit or other hospital facility, a search of this registry can then be conducted upon declaration of brain death to determine whether any objection by this patient has been stated, allowing for the appropriate course of action to be taken. If there is no objection, organs can be removed by surgeons, but if an objection exists, then no removal will take place. 

Presumed consent is a broad concept covering many variables that can, depending on the circumstances, be designed to suit the particular needs and sensitivities of different societies. While laws may permit medical authorities to remove organs should no objection be registered by the affected person, what is often followed is a “weak” form of presumed consent, where the family of the deceased is still allowed to veto the removal of organs, as happens in the opt-in system. While doctors may have the legal right to take organs without family consent, they can feel that legislation does not give them the moral right to engage in such activities, so in order to maintain good relations with the community, they may nonetheless feel obliged to ask the next of kin for approval as a form of moral safeguard[11]. Regardless of whether this self-imposed barrier is actually used or not, doctors may find that having the legal right to remove organs may facilitate their efforts to collect organs, as “the question … (regarding organ removal) … is asked automatically and everyone expects it”[12]. In addition, a system of presumed consent can also be adapted to facilitate the removal of only certain tissues and organs that are especially needed, while less restrictive criteria can be applied to the collection of less vitally needed components of the human body. What is often overlooked in many areas where informed consent systems operate is that laws may exist permitting coroners and other medical personnel to remove superficial tissues, in particular corneas, from cadavers without the knowledge of the deceased’s family. While the removal of such tissue may be permitted because the activities performed are deemed to be less invasive than organ removal, which entails substantial surgery on a cadaver, the logic of this approach can be extended to cover the procurement of specified internal organs as well. For example, under a modified presumed consent system, organs that are in high demand, such as kidneys, can be automatically collected if no personal objection has been registered, with the collection of other solid organs, such as hearts and livers, still requiring family approval[13].

There are several apparent advantages to this system. First, it is believed to be more efficient than an informed consent system as it can increase the quantity of organs collected for any given size potential donor pool. This is since it avoids the problem of not knowing and having to find out what the wishes of a potential organ donor are, as all that needs to be done is see if an objection to donate has been registered, rather than try to seek out an indication of consent. Second, presumed consent, especially in the “strong” version, is believed to be a more humane method of acquiring organs than informed consent, as organ procurement staff do not need to disturb the family of the deceased and pose what may be an unwelcome question during their time of grief[14]. Third, by allowing dissenters to register their objections to donation, this system ensures that individual conscience and rights are respected, as people continue to be legally allowed to make a choice without being punished for doing so. Indeed, this system may actually empower people, for by forcing them to consider death and discuss it with others, they are no longer able to shirk from assuming any responsibilities concerning their own bodies. Finally, presumed consent is believed to be one way in which private parties can foster increased communal attachment and help society when their private costs of altruism are low but when the applicable social benefit is high, which may explain why it has been adopted in countries with a strong communitarian ethic. This is since presumed consent is believed to take greater account of the needs of the community at large than a system of informed consent, with the giving of organs being seen as a moral duty rather than as an act of charity[15]. As one commentator stated when highlighting this point: “in the case of organ donation, altruism bears little expense. Whether or not we have a moral obligation is questionable, but, given the fact that we may all one day benefit from the “gift of life”, it is evident that the act of donation can be as much out of self-interest as it is an expression of societal concern. In refusing to donate, families of the deceased have chosen to eschew altruism and, in turn, effectively pass on their grief to others”[16]. 

There are a series of objections to this system that have greatly hampered its implementation on a wider basis. Technically, there may be immense difficulties in ensuring that individual wishes are accurately transmitted and registered by the relevant authorities. This could then lead to the occurrence of “false positive” donations, where organs are retrieved from dissenters who have failed to state their objections or whose objections, although stated, were not properly registered due to administrative or communications failures. Not only would it be costly to set up and maintain a centralised registry that could be easily and rapidly searched when a potential donor has died, but this system would have to be continuously updated, not only to account for the birth and death of people, but also to accommodate individuals whose desires with respect to donation have shifted[17]. Even then, opting out might only be viable for those who know the workings of the donation process and about how to state their wishes effectively – some people, especially itinerants and those on the margin of society, might not be reached by the public awareness and registration programmes that exist should presumed consent be introduced. Furthermore, doubts exist as to how efficient presumed consent truly is in acquiring organs relative to informed consent, with significant differences in organ collection rates existing even between neighbouring areas. Factors that may contribute to these discrepancies include variations in the rate at which objections to donation are noted (with women, children and minority groups being more likely to object to organ removal)[18]; different interpretations of the same law (i.e. following weak versus strong consent)[19]; or simply differences in the number of medical facilities involved in the collection and transplanting of organs. Finally, the underlying foundation used in introducing presumed consent, namely the public support expressed for transplantation, should not be used as a guiding principle when it comes to making public policy. This is since not only are opinion polls a poor substitute for a legal referendum, but the answers provided by respondents may not reflect their true intentions or else they may not fully understand the questions posed to them and their underlying implications. For example, while one Gallup poll in the USA found that 75% of respondents approved of organ transplantation and organ donation, only 27% indicated a personal willingness to donate their own organs after death[20]. Thus, it is clear that responses may not reflect intentions, in which case particular care should be taken when considering the introduction of something as sensitive as a presumed consent system.

Several ethical objections have also been raised against presumed consent, especially by libertarian critics, who feel that such a policy is analogous to totalitarianism and slavery[21]. This is since this policy is believed to have significantly less respect for individual autonomy than organ gifting or sale, as not only are people forced by the state into considering an issue of a personal and highly sensitive nature (i.e. their own deaths), but they are also compelled into publicly stating their unhappiness about donation when this should be a private matter[22]. In the USA, this opposition to presumed consent has been clearly noted by people living in states where the law allows for the removal of corneas and other tissues without the need for consent. Here, it has been suggested that such activities violate the fifth amendment of the American constitution as private property (i.e. body parts) are taken without due process and just compensation, although a response that is still to be tested holds that such acts could nonetheless be considered valid if effective ways of opting out exist[23]. This debate is of relevance to countries currently operating informed consent systems, as these often have legal systems that are similar in nature to the American system, with legal precedents set in one country being of value in another state as well. More generally, many people may register an objection to donation because of what they consider to be an abuse by government of its powers, even though they have no general problem with the concept of organ removal. Thus, although government may be acting in the name of science or for a clearly good cause, it is possible that organs will be lost simply because some people have socio-political views on this issue rather than limited altruistic values.

Finally, people may hesitate to support presumed consent systems since there is a fear that their use may lead to the introduction of a process known as routine organ salvaging[24]. After a presumed consent system has been in operation for a period of time, if the number of objections to organ removal becomes insignificant, government may argue that in order to save costs in maintaining and monitoring an objection register, it will no longer consider registering objections due to the limited rejection rate recorded, with the removal of organs henceforth being undertaken as a matter of general medical policy rather than as a matter of individual choice. Once such a change takes place, individual autonomy will no longer be respected, as any private objections that are raised to organ removal will no longer be considered, with the state in effect gaining the sole ownership rights over any organs that might be of use for transplant purposes.

 

iii) Required request

An amended approach to organ procurement that was suggested in 1984 by Arthur Caplan, a noted medical ethicist, is that of required request[25]. At best, this system can be described as imposing a partial restriction on the voluntarism associated with informed consent, since it involves the introduction of laws that make the request for organs conducted by medical staff mandatory rather than optional, as currently occurs with informed consent systems. In order to ensure compliance with this new policy, each medical institution would have to designate a trained person to request organs from potential donors, with details of the request and the result obtained having to be recorded in writing on the death certificate of the deceased person. While requesters would be entitled not to ask for organs if they believed conditions did not warrant such a position, this decision would also have to be recorded on the death certificate of the deceased, with medical administrators being able to examine all death records and make requesters account for any apparent failures to request organs. At the same time though, an important element of opting-in continues to remain in force, for although family members will now be compelled to face a request for donation, they will continue to retain their rights to refuse consent to such a procedure.

This policy of compelling medical staff to ask for organs can address many of the shortcomings of the informed consent system while retaining the structural strengths of this basic system. Most importantly, the opportunity to donate is maximised, for in addition to ensuring that an effort is made by requesters to search for an organ donor card, it ensures that even if no card is found, a second attempt at collecting organs can be made by empowering the family to make a decision on behalf of the deceased. By making requests for organ removal standard policy, members of the public can gradually come to expect such a measure as being a standard feature of hospital death, and are thus less likely to be shocked should they themselves be asked to agree to donation one day. In addition, knowledge that a request will be made can get them to discuss their personal beliefs with others should they too die in a hospital. Finally, this policy is said to add an extra level of protection to objectors by making sure that the only people who can authorise donations are family members who know of their views, while ensuring that any administrative failings that could happen if a presumed consent system was in operation do not happen[26]. 

Despite being seen as a more effective form of informed consent, required request has, as the experience in the USA demonstrates, its own particular drawbacks. While small-scale studies conducted at a few hospitals may result in greater short run collection rates, the applicability and durability of these donation levels to a whole population over the long run has proven to be less attainable[27]. While this procurement policy may be written down in law, an incentive to ask for organs must still exist, otherwise hospitals, especially those with no transplantation programmes of their own, may find ways of evading their obligations, with a consequent loss of organs to the system as a whole. There is also a human dimension to death that exceeds whatever the law may state, where physicians and medical staff might not be up to the task of asking for organs after losing a battle to save a patient’s life, even if the law compels them to do so. Furthermore, while the person entrusted with asking for organs might not actually be a member of a medical team, pressure might still be brought to bear against asking for organs if it is felt by doctors that asking is not an advisable strategy (even if this decision is outside their jurisdiction).

At other times, precisely the opposite situation may arise, where requesters are overzealous in their efforts and may badger the family to agree to organ donation by refusing to take “no” as an answer to their requests[28]. Alternatively, untold suffering can be inflicted if a patient is unnecessarily maintained on life support machines simply because requesters want to wait until the patient’s family can be contacted in order to try and obtain consent. While it could be argued that this continuation of life is humane and in keeping with general medical principles, one commentator literally let the cat out of the bag by observing that “the aim of supportive care … is to keep the organs in optimum condition for as long as is required for the transplant retrieval teams to arrive and harvest the organs”[29]. While this problem of artificially prolonging life can exist regardless of the procurement system in use, it is, however, likely to be more common if a required response system is in operation simply because the law compels medical staff to wait until they can get a reply from the family. In principle, this is undesirable, for not only must the family bear the emotional cost of seeing the deceased go through unwanted hardship, but they also have to bear certain financial consequences of this delay in ending a life. This is because they are usually the ones who must cover the substantial medical expenses incurred in keeping life support going between the period that brain death is formally declared and when a final decision concerning possible organ donation is made, even though no discernable benefit is received by either them or their loved ones from such a policy.

 

iv) Required response

One final method of altruistically acquiring organs that is worth examining is the system of required response, also known as mandated choice[30]. Under this system, all adults are required by law to express their personal preferences with respect to organ donation, with clarification having to be provided on matters such as which of their organs can be removed and who is to be delegated with the power to consent to the post-death removal of their organs. Such preferences can usually be indicated by people when they appear at traffic licensing departments to receive their driving licenses, although in cases where people do not drive, they can be made to indicate their choices when submitting income tax assessments, health insurance claims or application forms for a national identity document. Should people change their minds after registering their choices, they can amend their initial wishes when applying for new documents or, where applicable, change the appropriate answers if wishes are recorded on identity or driver’s cards.

The main advantage of introducing this system is that it actually forces people to contemplate death and consider the disposition of their property and body after dying. While this may again be seen as a coercive act or an invasion of privacy by the state, this method nonetheless promotes individual autonomy and responsibility by making a person personally determine what is to be done with their body once they eventually die. In addition, mandated choice reduces the stress that might be placed on a physician and family when a person dies should the issue of donation need to be raised – to the former, the burden of having to confront their failure at saving a life and of facing the unpredictable reaction of the distraught family is removed, while for the latter, the question of having to answer a request for consent (especially if required request is used) no longer needs to be faced.

In addition to the allegation that this system involves a coerced burden imposed by the state on citizens to consider an issue they may find to be undesirable, there is a fear that the use of required response laws can, over time, be used as an indirect way of introducing presumed consent laws into a country. If, as might be assumed, the number of people who agree to donation in terms of required response laws gradually increases, the need to check the records of individual patients will start to decrease as the probability of finding dissenters becomes ever smaller. Eventually, a constraint may be reached where a move towards presumed consent may be called for, with the rationale being that this can simplify administrative procedures in organ collection. Given that substantially greater numbers of people could eventually donate organs, it could then be argued that in order to avoid unnecessary costs and effort in searching for people opposing donation, a more effective measure would be to simply change over to presumed consent, where only those opposed to donation would have to register their wishes, rather than have the costs involved in getting the whole population to register their wishes[31].

 

Having examined the different ways in which organs are procured, we can now move on to consider the problems faced by physicians once an organ is available for transplantation. Here, difficulties arise in determining how a particular organ is to be allocated to one patient when there are several competing patients who may each have a valid medical reason to desire it, with various, sometimes conflicting mechanisms being used to allocate organs amongst patients.